Wuxi LENGE Purification Equipment Co.ltd (briefly as “LENGE” here) in China is a leading supplier of separation and purification equipment and cartridge filters in the world. It has recently launched a series of highly efficient polyethersulfone-based microfiltration cartridge filters, aimed at meeting the rapidly increased demand in the pharmaceutical and biopharmaceutical industry in China and abroad. LENGE PES microfiltration membrane cartridge filters have filtration performances superior to the similar filters on the market.
Since 2016, LENGE has set up project team, who developed PES filter membrane core technology with huge investment. The independent production of microporous filter membrane has made a great breakthrough, break the monopoly of foreign filtering giants in domestic high-end filtering market.
The PES membranes for making cartridge filters at LENGE were developed and commercialized using its owned proprietary membrane manufacturing technologies in clean rooms in a state-of-the-art facility. All raw materials used for membrane production were suitable for manufacturing pharmaceutical grade filters, and the production lines were designed and manufactured by a world-class membrane machine manufacturer. The operating conditions and procedures in the membrane manufacturing were computer controlled so that the membranes produced have precise pore sizes and desired mechanical and filtration performance properties. LENGE offers the following pore size rated PES filters with various filter lengths (0.5 - 40 inches) to match the dimension and sealing requirements for most cartridge housings currently available:
· 0.1 µm
· 0.22 µm (fully bacteria retentive)
· 0.45 µm
· 0.65 µm
LENGE PES membranes are highly asymmetric with a distinct uniform integral retention layer. The membranes have a high surface porosity and gradually increased pore size distribution in the direction facing upstream of filtration. Therefore, the membranes have a capability of retaining various sized particulates and biological species. LENGE PES membrane filters have the following distinguished characteristics:
· High flux
· High capacity
· High mechanical strength
· High porosity
· Low protein binding and adsorption
· Low leaching
· Low endotoxic
· Absolute Bacterial Retention (0.22 µm )
· Brevundimonas Diminuta(ATCC 19146) at 10E7
· CFU/cm2 Effective Filter Area
· Can Be Steam Sterilized Multiple Times
· High Dirt-Holding Capacity
· Low Extractables
· Excellent Hydrophilicity
LENGE PES filter cartridges were manufactured using animal-free all-polypropylene structural components (end caps, adapters, media support, inner core and outer cage). Our product quality assurance (QA) and quality control (QC) team applied our quality master plan to ensure that our products and manufacturing processes meet GMP requirements. A statistic method was applied to ensure that both membranes and filters meet required bubble point (related to integrity and pore sizes) and that the production process is consistent. In addition, each grade of filters was validated. The validation of bacterial B. diminuta retention for 0.22 µm rated pharmaceutical grade cartridges was performed in accordance with American Society of Testing and Materials (ASTM) method F838-05. Using this test methodology, 0.22 µm rated pharmaceutical grade filters retained greater than 1 x 107 CFU of B. diminuta per cm² of effective filter surface area.
The PES membranes at LENGE were developed and commercialized using its owned proprietary membrane manufacturing technologies in clean rooms with a state-of-the-art facility. All raw materials used for membrane production meet the pharmaceutical standards, regulations and requirements, the production lines were designed and manufactured by world-class membrane machine manufacturers. All the operating conditions and procedures were computer controlled so that the membranes produced have precisely controlled pore sizes, desired mechanical and filtration performance properties. The main advantages of LENGE PES filter membrane are as follows:
· Complies with United States Pharmacopeia (USP) Biological Reactivity Test, In Vivo <88> for biosafety, cytotoxicity, and hemolysis testing.
· For 0.22µm membrane, lot samples retain a minimum of 10E7 cfu/cm2 of Brevundimonas diminuta(ATCC19146) per latest ASTM F838, current revision.
· The optimized built-in highly asymmetric prefiltration layer for maximum flow and throughput performance.
· Hydrophilic membrane that wets out quickly and completely resulting in fast filtration with superior flow rates and high throughputs. Easily wet for reliable integrity testing.
· Very high compatibility over the whole pH range plus very low protein binding to ensure the maximum transmission of the active ingredients.
· Compatible with EtO, gamma irradiation, and SIP/autoclave methods of sterilization.
Besides the wide applications in the pharmaceutical and biotechnology industry, LENGE PES filters are suitable for use in many fields, such as foods and beverages, and biopharmaceutical. We will offer a great deal of assistance and cooperation to ensure our filters meet technical and regulatory needs in your industrial applications and operations. In this article, the application of PES membrane in biopharmaceutical industry and food and beverage industry is introduced in detail:
l Reducing bacteria filtration and eliminating bacteria filtration in the cell culture medium; Serum free medium for the removal of human Mycoplasma; Serum containing medium for the removal of Mycoplasma in mammals.
l Protect the sterile filter barrier after cell enrichment, or clarify and filter with deep filter; Remove residual cells as a sterile filtration barrier before entering the downstream process.
l Control the microbial content of buffer, water and cleaning fluid, remove most microorganisms or filter them.
l Pre filtration and final sterilization of bioengineering intermediates or final products.
l Sterilization and filtration of blood products, human or animal vaccines.
l Sterilization and filtration of monoclonal antibody final products.
l Sterilization and filtration of industrial chemicals such as ethanol and butanol.
l Sterilization and filtration of API products before freezing and spray filling.
l Sterilization and filtration of large infusion before filling.
l Reducing bacteria and eliminating bacteria filtration of traditional Chinese medicine injection.
l Sterilization and filtration of industrial water and bottle washing water.
Food and beverage
l Sterilization and filtration of bottled water
l Sterilization and filtration of pure draft beer
l Sterilization and filtration of wine
l Sterilization and filtration of syrup, soft drinks, etc
l Sterilization and filtration of industrial water and bottle washing water.
Besides the wide applications in the pharmaceutical and biotechnology industry, LENGE PES membranes are also suitable for use in other fields, such as medical, food and beverage, drinking water, microelectronics, fine chemicals, etc. We will offer a great deal of assistance and cooperation to ensure our membranes meet technical and regulatory needs in your industrial applications and operations.
For more information about LENGE PES membrane, please visit LENGE website:http://www.lengepurification.com/product/pleated-filter-cartridge/pes-membrane-pleated-filter-cartridge/polyethersulfonepesflat-membrane.html, or you can send us an email directly: firstname.lastname@example.org.
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